NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed
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ClinicalTrials.gov Identifier: NCT01098266 |
Recruitment Status :
Completed
First Posted : April 2, 2010
Results First Posted : September 17, 2019
Last Update Posted : September 17, 2019
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Malignant Pleural Mesothelioma |
Interventions |
Drug: NGR-hTNF plus Best Investigator's Choice (BIC) Drug: Placebo plus Best Investigator's Choice (BIC) |
Enrollment | 400 |
Recruitment Details | Study Period: April 12th, 2010(First enrolment); January 21st, 2013 (date of last enrolment); April 29th, 2014 (cut-off date). 15 clinical sites in Italy, 10 in UK, 7 in USA, 4 in Belgium, 2 in Canada, 2 in Netherland, 2 in Poland, 1 in Egypt, 1 in Ireland;1 in Sweden |
Pre-assignment Details | Before randomization, the physician had to decide for each patient if he/she was candidate to either Best Supportive Care (BSC) alone or combined with single-agent chemotherapy. |
Arm/Group Title | A: NGR-hTNF + BIC | B: Placebo+BIC |
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Arm/Group Description |
NGR-hTNF plus Best Investigator's Choice NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
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Placebo plus Best Investigator's Choice Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
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Period Title: Overall Study | ||
Started | 200 | 200 |
Completed | 193 | 193 |
Not Completed | 7 | 7 |
Reason Not Completed | ||
Physician Decision | 1 | 0 |
Death | 3 | 2 |
Withdrawal by Subject | 3 | 5 |
Arm/Group Title | A: NGR-hTNF + BIC | B: Placebo+BIC | Total | |
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Arm/Group Description |
NGR-hTNF plus Best Investigator's Choice NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
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Placebo plus Best Investigator's Choice Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
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Total of all reporting groups | |
Overall Number of Baseline Participants | 200 | 200 | 400 | |
Baseline Analysis Population Description |
Patients ≥ 18 years with advanced malignant pleural mesothelioma previously treated with a pemetrexed based chemotherapy regimen for advanced or metastatic disease.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 200 participants | 200 participants | 400 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
92 46.0%
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87 43.5%
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179 44.8%
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>=65 years |
108 54.0%
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113 56.5%
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221 55.3%
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 200 participants | 200 participants | 400 participants | |
65
(25 to 89)
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67
(31 to 81)
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66
(25 to 89)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 200 participants | 200 participants | 400 participants | |
Female |
44 22.0%
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55 27.5%
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99 24.8%
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Male |
156 78.0%
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145 72.5%
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301 75.3%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 200 participants | 200 participants | 400 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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1 0.5%
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1 0.3%
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|
Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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|
Black or African American |
2 1.0%
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0 0.0%
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2 0.5%
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White |
198 99.0%
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197 98.5%
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395 98.8%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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2 1.0%
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2 0.5%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 200 participants | 200 participants | 400 participants |
Canada | 3 | 5 | 8 | |
Netherlands | 5 | 2 | 7 | |
Sweden | 1 | 1 | 2 | |
Belgium | 5 | 8 | 13 | |
United States | 14 | 12 | 26 | |
Ireland | 3 | 1 | 4 | |
Egypt | 17 | 19 | 36 | |
Poland | 17 | 14 | 31 | |
Italy | 79 | 84 | 163 | |
United Kingdom | 49 | 46 | 95 | |
France | 4 | 6 | 10 | |
Spain | 3 | 2 | 5 |
Name/Title: | Clinical Operations |
Organization: | Molmed S.p.A |
Phone: | 003902212771 |
EMail: | clinical.operations@molmed.com |
Responsible Party: | AGC Biologics S.p.A. |
ClinicalTrials.gov Identifier: | NCT01098266 |
Other Study ID Numbers: |
NGR015 2009-016879-29 ( EudraCT Number ) |
First Submitted: | March 17, 2010 |
First Posted: | April 2, 2010 |
Results First Submitted: | June 5, 2019 |
Results First Posted: | September 17, 2019 |
Last Update Posted: | September 17, 2019 |